Status:
COMPLETED
Efficacy of Ferric Carboxymaltose With or Without EPO Reducing Red-cell Transfusion Packs in Hip Fracture Perioperative Period
Lead Sponsor:
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Conditions:
Hip Fractures
Eligibility:
All Genders
65+ years
Phase:
PHASE3
Brief Summary
In order to evaluate the efficacy of ferric carboxymaltose + erythropoietin versus ferric carboxymaltose versus placebo in reducing the percentage of patients who receive red-cell transfusion in the p...
Detailed Description
Three arms of treatments: A: ferric carboxymaltose and erythropoietin, B: ferric carboxymaltose and placebo, arm C: two placebos. Primary objective:reduction of red-cell packs needed for elderly patie...
Eligibility Criteria
Inclusion
- Patients 65 years and older.
- Osteoporotic hip fracture which require surgical intervention
- Haemoglobin levels between 90-120 g/L
- Signed informed consent form
Exclusion
- Bone marrow diseases which could interfere in the erythropoietic process (acute or chronic myelodysplastic syndromes or myeloproliferative diseases, and/or infiltration of the bone marrow due to solid or lymphatic neoplasms)
- Blood coagulation diseases or currently treated with oral anticoagulants and/or heparin at therapeutic doses.
- Documented allergy and/or previous intolerance and/or contraindication of erythropoietin use and/or intravenous iron.
- Patients with rheumatoid arthritis and/or another demonstrated origin of inflammatory anemia and/or not controlled arterial hypertension.
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
303 Patients enrolled
Trial Details
Trial ID
NCT01154491
Start Date
June 1 2010
End Date
May 1 2013
Last Update
July 28 2015
Active Locations (14)
Enter a location and click search to find clinical trials sorted by distance.
1
Hospital Universitario de Albacete
Albacete, Albacete, Spain, 02006
2
Hospital General Universitario de Elche
Elche, Alicante, Spain
3
Hospital de la Vega Baja
Orihuela, Alicante, Spain, 03314
4
Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain, 08915